Validation of EUROArray HPV test using the VALGENT framework.
Jessica Viti, Mario Poljak, Anja Oštrbenk, Ramya Bhatia, Elia Alcañiz Boada, Alyssa M Cornall, Kate Cuschieri, Suzanne Garland, Lan Xu, Marc Arbyn
Journal of Clinical Virology | Published : 2018
BACKGROUND: Robust clinical and analytical validation of human papillomavirus (HPV) tests is a pre-requisite for their use in cervical cancer screening given the transience of most high-risk HPV infections. OBJECTIVES: To evaluate the EUROArray HPV test (PCR-based full HPV genotyping test) using the international validation of the VALGENT framework, which offers an opportunity to determine analytical and clinical performance according to internationally accepted performance metrics. STUDY DESIGN: A total of 1300 consecutive and 300 abnormal cervical samples derived from the Slovenian screening programme were tested with the EUROArray HPV test. Clinical performance for the detection of cervic..View full abstract